A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Time to First Occurrence of Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event, Defined as a Composite of CV Death, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke [ Time Frame: Baseline up to 4.9 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to First Occurrence of Expanded Composite Endpoint, Defined as a Composite of CV Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Non-Elective Coronary Revascularization Procedures, and Hospitalization for Unstable Angina [ Time Frame: Baseline up to 4.9 years ] [ Designated as safety issue: No ]

Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 4.9 years ] [ Designated as safety issue: No ]

History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis

At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >= 4 weeks

Exclusion Criteria:

Major surgery (including joint surgery or coronary revascularization) within 8 weeks prior to screening or planned major surgery within 1 year of study start

History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations

Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion

Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds

Any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit

Latent TB diagnosed during screening that has not been appropriately treated

Primary or secondary immunodeficiency (history of or currently active)

Moderate to severe heart failure

Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years

Breast feeding mothers

History of alcohol, drug or chemical abuse within the 6 months prior to screening

Immunization with a live/attenuated vaccine within 4 weeks prior to baseline visit

Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837